Building the Blocks of Life: Operations Management at Orca Bio

Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Founded in 2016 and built on research conducted in the laboratory of stem cell pioneer Dr. Irv Weissman, the company is redefining the traditional transplant process by developing next-generation cell therapies designed to provide better outcomes with fewer risks and higher survival rates. Orca Bio's purified, high-precision investigational cell therapies aim to replace patients' blood and immune systems with healthy ones and restore their lives.

Facing continuous growth, the team at Orca Bio quickly realized that fulfilling their mission would require operations to scale and optimize fast. Efficiently navigating a geographically dispersed network of clinical outlets for procuring source grafts and distributing processed treatments was a significant challenge, compounded by a reliance on home-grown applications and spreadsheets.

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Inventory management, asset management, production operations, and advanced scheduling all needed to be optimized or enabled, but existing applications did not facilitate interoperability, creating information silos that stifled cross-departmental collaboration.

That's where TrakSYS and Parsec Automation, LLC Certified Partner InflexionPoint came in. InflexionPoint worked closely with Orca Bio in a series of summer-long workshops to understand the business and how current practices were or were not aligning with the company's mission. With clarity of vision established, the team tackled several manufacturing operations use cases in parallel: asset management, inventory management, clinical integration, production operations management, track and trace/labeling, quality management, and scheduling.

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TrakSYS was implemented at Orca Bio's primary facility (SAC1) in Sacramento, replacing the existing inventory management system and enabling expansion to a second full-scale production facility, SAC2. TrakSYS also replaced the homegrown asset tracking system with a full-featured asset management system, becoming the heart of the company's production by coordinating material movement, tracking equipment and room allocation, and supporting a fully qualified electronic batch record for every production run.

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Through its interoperability, TrakSYS was configured to work with Orca Bio's external clinical systems to track the receipt of patient graft materials and support coordinated delivery of resulting treatments. TrakSYS Algorithmic Production Scheduling was implemented to track production demand against material availability, logistics capability, personnel availability, and equipment capacity, since rapid processing time for each customized cell therapy batch is vital to the patients Orca Bio serves.

TrakSYS has enabled Orca Bio to scale production operations confidently by ensuring its processes are clearly defined, validated, and ready for expansion. The platform optimized inventory-related production activities by over 50% and streamlined inventory management and accuracy.

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Orca Bio can now immediately integrate production and maintenance activities to reduce or eliminate unplanned downtime, accurately forecast equipment availability, and significantly increase overall throughput. The company also established a computer systems validation program for TrakSYS to maintain ongoing internal compliance, orchestrating processes from inventory and asset management to operations and scheduling as it shifts from clinical to full-scale volume production.